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    Senior Manager Regulatory CMC - United Kingdom - BioTalent

    BioTalent
    Default job background
    Pharmaceutical / Bio-tech
    Description

    BioTalent are pleased to be supporting a longstanding client, a mid-sized biopharmaceutical business with offices across Europe, in their search for a Senior Manager Regulatory CMC, responsible for Dossier Management.

    The client would like to speak to candidates with experience in:

    • Development activities for Biologics in the EU and US.
    • Post-approval activities for Biologics in International markets (China, Russia, Latam, Asia etc.)
    • OR pre and post approval activities for small molecule products - Global experience.

    Responsibilities would include:

    • Dossier Strategy
    • Authoring CMC dossier sections
    • Developing the technical eCTD sections to support Regulatory CMC dossier applications
    • Interfacing with internal and external functional stakeholders

    The role can be worked from Switzerland, Sweden, France or the UK.

    3 days per week in the Basel office

    2 days per week in the Stockholm office

    Remote in the UK and France



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